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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Merck |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00831493 |
Purpose
Primary Endpoint:
To determine the maximum tolerated dose (MTD) of vorinostat + radiation therapy (RT) in patients with locally advanced pancreatic cancer (LAPC).
Secondary Endpoints:
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Radiation: Chemoradiation (Radiation Therapy) Drug: Vorinostat |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Trial of Vorinostat and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer |
| Enrollment: | 3 |
| Study Start Date: | May 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vorinostat + Radiation Therapy
Vorinostat Starting Dose of 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gy in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
|
Radiation: Chemoradiation (Radiation Therapy)
Dose of 50.4 Gy in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
Other Names:
Drug: Vorinostat
Starting Dose of 200 mg orally once daily, Monday to Friday, Weeks 1 to 6.
Other Names:
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The Study Drugs:
Vorinostat is designed to interfere with the growth of cancer cells.
Study Drug Dose Level:
If you are found to be eligible to take part in the study, you will begin receiving vorinostat. The dose you receive will be based on how many participants have been enrolled before you, and on the safety data available. The first group of 3 enrolled participants will be given low doses of vorinostat. If no intolerable side effects occur, the next group of 3 will be enrolled at a higher dose level. The study doctor will tell you what dose you will be receiving and how it compares to the doses other participants have received. Up to 3 dose levels will be tested.
Study Drug Administration:
On each day that you receive radiation, you will take vorinostat (as a capsule taken by mouth) in the morning with food.
Radiation:
You will receive radiation once a day on Monday through Friday, except for holidays. This schedule will be continued for 5 1/2 weeks or 28 doses total. Each radiation treatment will usually last about 10-15 minutes.
Surgical Evaluation:
After completing radiation therapy, you will come back for a follow-up visit about 6-12 weeks later.
Length of Study:
You will remain on study for up to 5 1/2 weeks. You will be taken off-study early if the disease gets worse or intolerable side effects occur.
This is an investigational study. Vorinostat is FDA approved and commercially available. The use of vorinostat for pancreatic cancer and in combination with radiation is investigational. At this time, this combination is being used in research only.
Up to 37 patients will take part in the study. All will be enrolled at M. D. Anderson.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Sunil Krishnan, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00831493 History of Changes |
| Other Study ID Numbers: | 2008-0780 |
| Study First Received: | January 27, 2009 |
| Last Updated: | October 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Pancreas Pancreatic Cancer Locally Advanced Pancreatic Cancer LAPC Non-Metastatic Unresectable Vorinostat |
XRT RT Radiation Therapy SAHA Suberoylanilide Hydroxamic Acid MSK-390 |
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
Vorinostat Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |